No Cause Of Action Against Doctors Or LASIK Manufacturer.

Two plaintiffs received laser eye surgery, LASIK. They brought an action against the machine manufacturer and various doctors because the laser machine used had not been approved by the Food and Drug Administration, even though they suffered no injuries during their surgeries. They assert claims under the Human Subjects Act [Health and Safety Code section 24271], which requires informed consent before a person can be subjected to any medical experiment. They also assert fraud by omission, a violation of the Federal Food, Drug and Cosmetic Act [FDCA] and request an injunction under the California Legal Remedies Act. The Ninth Circuit affirmed the district court’s dismissal of the action, finding the plaintiffs were not subjects within the meaning of the Human Subjects Act, their claim under the federal act is impliedly preempted because it amounts to an attempt to privately enforce the FDCA, their fraud by omission claim is expressly preempted by the FDCA. The court noted there is a narrow gap through which a state-law claim must fit to escape preemption by the FDCA:  “The plaintiff must be suing for conduct that violates the FDCA, but the plaintiff must not be suing because the conduct violates the FDCA.” Perez v. Nydek Co. LTD. (Ninth Cir.; March 25, 2013) (Case No. 10-55577).